This Tender Has Expired

Compulsory Briefing Session: Monday, 04 May 2026, 10:00-11:00. Virtual via Microsoft Teams: Join link: https://teams.microsoft.com/meet/37879484560535?p=idMceGxSuIBWlFfEm1. Meeting ID: 378 794 845 605 35. Passcode: NJ968L7z. Clarification deadline: Submit written queries to [email protected] by Thursday, 14 May 2026. Answers uploaded to SAHPRA website on Friday, 15 May 2026. Closing date: Thursday, 21 May 2026 at 11:00 am.

SCM/Technical contact: Malose Teffo. Email: [email protected]. Submission address: Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0083. Office hours for submissions: 08:30-16:00, Mondays to Fridays.

Submit bids as follows: One (1) original document plus two (2) copies and one (1) USB. Deliver to: Loftus Park, Building A, 402 Kirkness St, Arcadia, Pretoria, 0083. Bids must be in a sealed envelope marked with: BID NUMBER (SAHPRA/2026/AI TECHNOLOGY CONSULTANT/RFB007), closing date and time (Thursday, 21 May 2026 @ 11:00 am), and the name/address of the bidder. Bids can only be deposited into the tender box or handed in at the second floor during office hours (08:30-16:00, Mondays to Fridays) before or on the closing date. No posted, faxed, or e-mailed bids accepted. Late bids (even one second after 11:00 am) will be returned unopened. Official Telkom time (dial 1026) verifies closing time. Bid validity: 90 days from closing date. Documents submitted on time will not be returned.

Compliance requirements for responsiveness: Submit all of the following: 1) Signed Special Conditions of Bid and Contract, 2) Proof of tax compliance (SARS PIN or TCS certificate), 3) Completed and signed Declaration of Interest (SBD 4), 4) Completed and signed Invitation to Bid (SBD 1), 5) Completed Pricing Schedule (SBD 3.3) in prescribed format, 6) Proof of CSD registration, 7) Three client reference letters with cumulative service period exceeding two (2) years. Functionality evaluation (70 points total): Experience & Track Record (25 points): Three compliant references with >2 years cumulative experience = 25 points. Technical Expertise (AI Engineer) (15 points): >3 years experience with AI/ML certification and degree = 15 points. Technical Expertise (Software Engineer) (10 points): >3 years experience with certification/degree = 10 points. Testing and Validation Plan (15 points): Thorough plan with clear methodology and success criteria = 15 points. Project Management and Timelines (5 points): Well-defined timeline with milestones and contingency planning = 5 points. Minimum functionality score to proceed: 55/70. AI Tool Demonstration (30 points): Must provide a demonstration of the AI tool based on a reference sample. Minimum demonstration threshold: 22.5/30. Price and Specific Goals (80/20 system): 80 points for price, 20 points for B-BBEE/specific goals. Final award: Highest total points (price + functionality + specific goals).

Scope: 36-month contract (option to renew for 24 months) to design, develop, test, implement, integrate, validate, and maintain AI technical tools/platforms for SAHPRA. Purpose: Support SAHPRA’s vision of a risk-based, data-driven, AI-enabled regulatory environment to improve efficiency, innovation, and decision-making. Key use cases (prioritized): Tier 1 (Quick Wins): Technical Screening Tool – MA Variations (Type I focus), LASA Tool (Look-Alike, Sound-Alike Similarity Checker), Site Surveillance Tool. Tier 2 (Strategic High-Impact): PI/PIL Comparison Tool, ZAPAR Reporting Tool, BA/BE Review Tool, Online Surveillance Tool (Crawler). Tier 3 (Complex Strategic): APPMS System, Technical Screening Tool – CT. Data Security: All code and data must remain strictly local (no external/cloud platforms). Compliance: POPIA, GDPR (where applicable), SAHPRA data security/privacy policies, FDA 21 CFR Part 11, GAMP5, EMA Annex 11. Technical Stack: Containerization (Docker), Python 3.9+, FastAPI, PyTorch/TensorFlow, CUDA, PostgreSQL, MongoDB, OCR (Tesseract), web scraping, local LLM execution (Ollama/vLLM), MLflow/DVC for model management. Deliverables: Inception Report, Implementation Plan, URS/FRS, System Architecture, API documentation (OpenAPI 3.1), source code (version-controlled), test plans (IQ/OQ/PQ/UAT), validation reports, deployment guides, user manuals, training materials, SOPs, knowledge transfer documentation. Team Requirements: Minimum roles: Solutions Architect (1), Senior Software Engineers (2), Software Developers (2), AI Engineers (2), ML Engineers (2), Data Scientist (1), Prompt Engineer (1), DevOps Engineer (1), Data Engineer (1), OCR/Document Processing Specialist (1), Validation Officer (1), QA/Test Engineers (2), Security/Compliance Specialist (1), Project Manager (1), Business Analyst (1), Training Specialist (1). On-site work at SAHPRA’s Pretoria office may be required for specific phases.

Pricing: Submit completed Pricing Schedule (SBD 3.3) in prescribed format. Price for 36 months must be firm. Total cost for 36 months (VAT exclusive and inclusive) must be specified. VAT must be shown separately at 15%. Support services: Fixed hourly rate (VAT inclusive) for all support and maintenance activities. Payment terms: 30 days after receipt of invoice. Bid validity: 90 days from closing date. Non-compliance with pricing format or missing totals renders bid non-responsive.

Mandatory for responsiveness: Registered on Central Supplier Database (CSD). Submit proof of CSD registration or application. Tax Compliance: Submit SARS PIN or TCS certificate (printed or via e-filing). B-BBEE: Submit valid B-BBEE certificate or sworn affidavit (for EMEs/QSEs). Required forms: Signed Special Conditions of Bid and Contract (SBD 1), completed and signed Declaration of Interest (SBD 4), completed and signed Preference Points Claim Form (SBD 6.1), completed and signed Invitation to Bid (SBD 1). Subcontracting: If applicable, submit proof of subcontractor’s CSD registration and B-BBEE status. Non-compliance with any mandatory requirement renders bid non-responsive. Additional: No bids from state employees or entities with state-employed directors/members.